Yamada Yasuhiro, Shiaishi Takumi, Ueno Akihisa, Kaneko Masatomo, Inoue Yuta, Fujihara Atsuko, Hongo Fumiya, Ukimura Osamu
Department of Urology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Contemp Clin Trials Commun. 2019 Oct 12;16:100471. doi: 10.1016/j.conctc.2019.100471. eCollection 2019 Dec.
Whole-gland therapy for prostate cancer, which might cause more harm than no therapy (observation or active surveillance), might be a overtreatment. In order to avoid overtreatment as well as undertreatment of localize prostate cancer, novel strategy of organ-preserving therapies have been developed to achieve both cancer control and functional preservation. For the therapeutic techniques, microwave ablation would be an option for lesion-targeted focal therapy to eradicate biopsy-proven cancer lesion with its safety margin. Following our recent pilot clinical study of lesion-targeted focal cryotherapy, prospective clinical trial was designed to investigate the safety and therapeutic effects of lesion-targeted microwave therapy for localized prostate cancer.
This is a single-center, phase I, clinical study to evaluate primarily the safety of lesion-targeted focal microwave treatment for prostate cancer. Patients with a magnetic resonance imaging (MRI)-visible, MR-ultrasound image-fusion targeted biopsy-proven clinically significant cancer will be enrolled. The target sample size is 5. Transrectal ultrasound-guided focal microwave ablation will be performed under general anesthesia. The primary endpoint is adverse events after microwave focal therapy. Secondary endpoint includes to assess both cancer control and quality of life (functional preservation).
This single-center, phase I, clinical study aims to evaluate the safety and efficacy of lesion-targeted focal microwave treatment for prostate cancer. The importance of this clinical trial is that it may establish new treatment for prostate cancer.
This study was registered with Japan Registry of Clinical Trials (jRCTs052190026).
前列腺癌的全腺体治疗可能比不进行治疗（观察或主动监测）造成更多伤害，可能属于过度治疗。为了避免对局限性前列腺癌的过度治疗以及治疗不足，已开发出新型的器官保留治疗策略，以实现癌症控制和功能保留。对于治疗技术而言，微波消融可作为一种针对病变的局部治疗选择，用于根除经活检证实的癌性病变及其安全边缘。继我们最近针对病变靶向局部冷冻治疗的试点临床研究之后，设计了一项前瞻性临床试验，以研究病变靶向微波治疗局限性前列腺癌的安全性和治疗效果。
这是一项单中心的I期临床研究，主要评估病变靶向局部微波治疗前列腺癌的安全性。将纳入经磁共振成像（MRI）可见、磁共振超声图像融合靶向活检证实为具有临床意义的癌症患者。目标样本量为5例。经直肠超声引导下的局部微波消融将在全身麻醉下进行。主要终点是微波局部治疗后的不良事件。次要终点包括评估癌症控制情况和生活质量（功能保留）。
这项单中心的I期临床研究旨在评估病变靶向局部微波治疗前列腺癌的安全性和疗效。该临床试验的重要性在于它可能为前列腺癌建立新的治疗方法。
本研究已在日本临床试验注册中心（jRCTs052190026）注册。
